When is a negative actually a plus? When it s

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1 2 / CAP T O D A Y June 25 Immuassay market overflowing with change Anne Ford When is a negative actually a plus? When it s a negative predictive value, or NPV, that makes it possible for emergency medicine departments to exclude particular diagses. To that end, biomérieux recently introduced the Vidas D-Dimer Exclusion assay the first and only F D A - c l e a red D-dimer assay for the exclusion of deep vein thrombosis and pulmonary embolism in outpatients presenting to the emergency department, says marketing manager Vince Tu m- minello. The Vidas D-Dimer Exclusion offers a 99.9 percent NPV. For something negative, that sounds awfully positive. The Vidas D-Dimer Exclusion is just one of myriad new assays for the immuassay analyzers p rofiled in this month s instrumentation survey. With at least 3 assays recently or soon to be launchedto say thing of multiple new analyzers and a number of software upgradeslaboratories are presented with an abundance of riches. Take The Binding Site. We ve greatly expanded our menu offering on the DSX [analyzer] over the past year, marketing manager Gary Tremain says. We ve added an automated anti-ccp and a C1q binding circulating immune complex assay, expanded our celiac disease panel with ttg IgG, and launched a whole new line of infectious disease markers, such as those for mumps, Lyme disease, H. pylori, and syphilis. The Binding Site s customers can also look forward to the impending release of updated software for the DSX analyzer. The software, Tremain says, incorporates many cust o m e r- requested features, such as an impro v e d continuous sample load feature, a new deep-well incubation feature, and greater ease of use. Beckman Coulter s list of forthcoming assays is similarly long. We re going to launch anyw h e re from seven to 1 new assays by the end of the year, including intact PTH, says Jim Rigo, global marketing manager for immudiagstics. That includes new tests for anemia, skeletal, c a rdiac, and more. The new anemia assays will include an assay for EPO and soluble transferrin re c e p t o r. Earlier this year, Beckman Coulter int roduced a fast htsh, an intrinsic factor, and an enhanced free T 3 test, along with an enhanced test for folate and RBC folate. The company will also launch its new chemistry-immuassay system, the UniCel DxC 6i, later this year. Tosoh has the second-generation AIA-36 under development with the primary change resulting in expanded test menu capabilities. Hepatitis B markers are in the final stages of optimization in the ST format and will be released as soon as they clear the regulatory process. As with all Tosoh analytes, these assays will be available on Tosoh A I A p l a t f o r m s. Nichols Institute Diagstics recently added ald o s t e rone, H-hCG, IGF-I and IGFBP-3 with ageand gender-specific re f e rence ranges, and Tg with recovery to the menu of its Nichols A d v a n t a g e Specialty System immuassay analyzer. And this summer, DiaSorin is planning to int roduce three assays on its Liaison chemiluminescent system: EBV IgM, VCA IgG, and EBNA IgG. These assays will complement our existing menu of 25-OH vitamin D and intact PTH, says p roduct manager Mari Kelly. The DiaSorin EBV assays will be the first automated EBV chemiluminescence assays on the U.S. market. The time to first result is only 35 minutes. Rounding out the bunch are Hycor, which plans to continue to expand the product menu of its Hy Tec 288 instrument to include infectious disease assays, and Randox, which, says U.S. business manager Stuart Menary, has a wide range of assays currently in development, including expansion of routine parameters as well as more esoteric parameters like a maternal scre e n- ing array, cere b rovascular array, and further applications for screening, diagsis, and monitoring of various tumors. In addition to the scores of new assays, vendors a re flaunting new instruments, such as Olympus America s AU3i automated immuassay system. We will begin placing the AU3i at customer sites in Europe later this year, and we anticipate release in the States in early 26, says B ruce Gernaey, director of marketing. In the first year of launch, we ll have a 2-test menu including thyroid, fertility, cardiac, and tumor markers. In 27 we plan to add additional tumor markers, anemia, and infectious disease assays. The new instrument will be available as a standalone analyzer or as part of a workcell with Olympus AU chemistry systems. Visitors to the annual meeting of the A m e r i c a n Association for Clinical Chemistry should keep an eye out for two new instruments from A b b o t t the A rchitect i1sr immuassay analyzer and the A rchitect c16 chemistry system. These i n s t ruments will utilize common reagents, common software, common sample management, and common detection techlogy of our current A rchitect systems, U.S. product manager Chris Dillman reports. Also scheduled for availability this summer is Bayer s Advia Centaur CP immuassay system, which John Leach, global senior marketing manager in immulogy marketing for Bayer Health Care Diagstics Division, calls a compact benchtop system designed to maximize pro d u c t i v i t y. The Advia Centaur CP uses the same reagents, sample tips, and cuvettes as the full-size Advia Centaur, and offers a t h roughput of 18 tests per hour along with a menu of disease state assay groups. It s the ideal solution for the specialty testing center or laboratory with a high stat workload, Leach says. I n s t ruments already introduced include Randox s Evidence analyzer, based on biochip array t e c h n o l o g y, which, says Menary, promotes a m o re holistic approach to disease diagsis. He adds, Simultaneous detection of multiple analytes on a biochip offers much higher test thro u g h p u t than conventional systems. Complete automation of the tests offers full sample, reagent, and inventory tracking as well as the flexibility to re q u e s t only those analytes ord e red by the physician. Randox also recently launched the Evidence Inv e s t i g a t o r, a semiautomated biochip array benchtop analyzer Menary calls suited to lowert h roughput clinical laboratories and re s e a rch applications due to the rapidly expanding test portfolio. Diagstic Products Corp. s recently introduced Immulite 25 SMS offers an optional robotic sample management system. DPC plans to launch an immuassay workcell before A A C C. Senior marketing manager Mark Smith says, The open design of the sample management system enables the unit to become a single sample-entry point for two Immulite 2/25 systems, creating the immuassay workcell. In the workcell configuration, even though the systems are linked, they are functionally independent: If one system is unavailable, testing can continue on the other. Smith also touts his company s new Rea l Time Solutions, a support service that includes online reports such as Levey-Jennings re p o r t s, peer group reports, adjustment reports, and target range reports, viewable from any computer with Internet access. Then, too, customers can begin looking for imp rovements to the software of instruments that w e re launched as early as last year. In mid-24, P h armacia Diagstics introduced its Immu- C A P 25 system, a mid-sized continuous random access allergy diagstics instrument. The system s software, which could already link to the I m m u n o C A P 1, can w connect to Imm u n o C A P 1E instruments as well, eliminating the need to learn more than one software program, says senior product manager Lorraine Damico. The new command-central software can link up to 15 ImmuCAP i n s t ruments with a lab s information system. Other features include setting inventory re o rder points, printing of re o rder lists, and viewing lot numbers and expiration dates of onboard and externally store d reagents, plus optional remote service capability. All that t eugh for you? Aw a reness Te c h- logy has a chemiluminescent microwell re a d- er in re s e a rch and development; this year s A A C C attendees will be able to see a prototype. Wi t h- in nine to 12 months, we also hope to have an eight-channel microplate reader released to market, says sales manager Chris Schneider. Tr i n i t y Biotech marketing manager Marlene Jinks says studies w show that the company s Nexgen Four instrument, which has dual independent robotic pipetting arms, saves up to 45 minutes over traditional one-arm sequential micro p l a t e p rocessing instruments for full-load runs. A n d Diamedix s Parsec System, introduced at the 24 AACC meeting, is on schedule for delivery in the second quarter of this year. The system, says marketing manager Linda Schwartz, is designed with modularity and flexibility: Modularity provides the ability to simultaneously run diff e re n t techlogies such as EIA, chemiluminescence, I FA, and histopathology, while flexibility... offers the ability to build the Parsec system to [the c u s t o m e r s] specific needs. CAP TODAY s survey of immuassay analyzers includes products from the manufacture r s named above and from Bio-Rad, Dade Behring, Grifols USA, Ortho-Clinical Diagstics, and Roche Diagstics. Vendors supplied the information listed in the tables. Readers interested in a particular analyzer should confirm that it has the stated features and capabilities. Anne Ford is a writer in Chicago. FILE NEW& PROOFNEW June Page 2

2 June 25 C A P TODAY / 2 1 Automated immuassay analyzers Part 1 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Abbott Diagstics Nathaniel Pritchett nat.pritchett@abbott.com 1 Abbott Park Rd., Dept. ZZ2, AP6C-5 Abbott Park, IL AxSym Plus/1993 worldwide, 1994 U.S./U.S. U.S./U.S. 2,8/16, cont. random access/stat, batch floor-standing/segment 6.5 x 63 x 33.5 in/14.6 sq ft htsh II, TT3, TT4, FT3, FT4, T-uptake, total βhcg, FSH, LH, estrad., prolac., testosterone, CK-MB, homocysteine, myogl., trop. I, PSA, tpsa, fpsa, CEA, CA 125, C A 1 5-3, AFP, CMV IgG, rubella IgG & IgM, toxo IgG & IgM, carbamazep., digox., gentamicin, NAPA, phenytoin, phebarb., procain., quinidine, theoph., tobramycin, valp. acid, vanc., amph/meth, barbit., benzodiazep., cannab., cocaine met., methadone, opiates, PCP, acetamin., ethal, salicylates, tricyc., anti-tpo & TG, cortisol, BNP, anti-hcv, HAVAB 2., HAVAB-M2. B12 B12, folate, ferritin, CA 19-9, AUSAB, CORE, CORE-M, HAVAB 2. quant, HBsAg, HBsAg confirm, HIV combo, HIV 1/2, progesterone, CMV IgM, β-2-microglobulin, insulin, 3rd gen TSH, digitoxin, HBe, anti-hbe B12, folate, ferritin, CA 19-9, AUSAB, CORE, CORE-M, HAVAB 2. quant, HBsAg, HBsAg confirm, HIV combo, HIV 1/2, progesterone, CMV IgM, β-2-microglobulin, insulin, 3rd gen TSH, digitoxin, HBe, anti-hbe Abbott Diagstics Chris Dillman christopher.dillman@abbott.com 1 Abbott Park Rd., Dept. ZZ2, AP6C-5 Abbott Park, IL Architect i2sr; i2; i4//u.s. U.S./U.S. 88/2,5 batch, random access, cont. random access/floor-standing/track & LAS i2sr, 48 x 61 x 49/2.3 sq ft; i2, 48 x 68 x 44 in/22.7 sq ft per module troponin I, CK-MB, myoglobin, TSH, free T3 & T4, total T3 & T4, T-uptake, β-hcg, estradiol, FSH, LH, progesterone, prolactin, CA 125, CA 15-3, CEA, free & total PSA AFP, B12, folate, ferritin, testosterone testosterone, B12, folate, RBC folate, ferritin, AFP, CA 19-9, pepsigen I & II, SCC, anti-hcv, HBsAg, HBsAg confirm, HAVAB-IgM, HAVAB-IgG, anti-hbs anti- HBc, anti-hbc IgM, anti-hbe, HBeAg, HIV Ag/Ab combo, anti-tg & TPO BNP, β-2-microglobulin, cyclosporine, sirolimus, tacrolimus, anti-ccp, C-peptide, cortisol, homocysteine, vitamin D, CMV IgG, CMV IgM, rubella IgG & IgM, TOXO IgG & IgM, estriol, PTH, RBC folate, CA 19-9, pepsigen I & II, SCC, anti-hcv, HBsAg, HBsAG confirm, HAVAB-IgM, HAVAB-IgG, anti-hbs, anti-hbc, anti-hbc IgM, anti-hbe, HBeAg, HIV Ag/Ab combo ne ne FPIA, MEIA, ion capture, REA/heterogeneous, bead (microparticle), fiber matrix filter 2 2 2/1 onboard reagent stability: 112, 224, 336/ /assay name, reag. lot No., expir. date, pack No. ID /<.1 ppm 6/9/9 /liquid /9 reaction vessels 83 ul/15 ul 1 ul/73 ul for sample cup, 45 ul for aliquot, 4.5 ml for primary (soft close of files only)/optional / decibels /1 & 75 mm/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / seconds 6 pt. or 2 pt. w/ master calib., index calib. /4 weeks / (up to 4 curves/analyte) shortest interval: 8 hr, longest: / //1 min Chemiflex (enhanced chemiluminescence) w/5 flexible protocols/magnetic microparticle /1-test & 5-test per kit 3 days/3 days/ (2 12ºC) /assay No., reagent serial No., lot No., tests per kit, exp. date, onboard stability time, master calibration curve / 3/135/12,5 /liquid /1,2 / 5 ul 15 ul/5 ul for all tube types / / 48 7 decibels /1 16 mm diameter, up to 75 1 mm height/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / <2 seconds 2 6 pt. curve /minimum 3 days or once per lot / 3 levels every 24 h for quantitative, 2 levels for qualitative / //1 min Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists 1 min 3 sec from standby tests/flexible platformload list dependent () / onboard/ all major LIS vendors (broadcast download & host query) //, Abbott Link 12 hr 5 months/within 12 hr per customer request daily: 14 min; weekly: 65 min; monthly: 11 min / $124,/2 IA tests per day $16,8 extended hours coverage / menu, reliability, online exception help, pressure monitoring, clot detection, ratio calculation, stat TAT 15.6 min <2 sec 67/2 tests per hour / onboard/ all major LIS vendors (broadcast download & host query) //, Abbott Link 8 business hr 11 weeks/ daily: <1 min; weekly: <1 min; monthly: ne / $169,5/5 immuassays per day / Chemiflex techlogy delivers excellent sensitivities and extended linearities while the RSH allows for priority and routine samples to be processed simultaneously without compromising stats Survey editor: Raymond Aller, MD CMYK Page 2 1

3 2 2 / CAP T O D A Y June 25 Automated immuassay analyzers Part 2 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Abbott Diagstics Chris Dillman christopher.dillman@abbott.com 1 Abbott Park Rd., Dept. ZZ2, AP6C-5 Abbott Park, IL Architect ci82/23/u.s. U.S./U.S. 55/321 batch, random access, cont. random access/floor-standing/features a patented Retest Sample Handler that uses multi-dimensional sample handling 48 x 127 x 49 in/43.2 sq ft trop. I, CK-MB, myoglobin, TSH, free T3 & T4, Total T3 & T4, T-uptake, β-hcg, estradiol, FSH, LH, progesterone, prolactin, CA 125 & 15-3, CEA, free & total PSA, acid phosphatase, albumin BCG & BCP, alkaline phosphatase, ALT, ALT Act, amylase, AST, AST Act, bilirubin (direct, total & neonatal), calcium, cholesterol, CK, CO2, creatinine, DLDL, GGT, glucose, iron, lactic acid, LDH, lipase, magnesium, phosphorus, TIBC, total protein, triglyceride, urea nitrogen, uric acid, chloride, potassium, sodium, amphet/meth, others (contact company for full test menu) AFP, B12, folate, ferritin, testosterone ferritin, ASO, hscrp testosterone, B-12, folate, RBC folate, ferritin, AFP, CA 19-9, pepsigen I & II, SCC, anti-hcv, HBsAg, HBsAg confirm, HAVAB-IgM, HAVAB-IgG, anti-hbs, anti- HBc, anti-hbc IgM, anti-hbe, HBe Ag, HIV Ag/Ab combo, anti-tg & TPO (contact company for full test menu) BNP, β-2-micro., cyclosporine, sirolimus, tacrolimus, anti-ccp, C-peptide, cortisol, homocyst., vit. D, CMV IgG/IgM, rubella IgG/IgM, toxo IgG/IgM, estriol, PTH, B-12, folate, ferritin, AFP, lithium, ammonia, D-dimer, others Awareness Techlogy Inc. Chris Schneider info@awaretech.com 1935 SW Martin Hwy. Palm City, FL ChemWell/1998/U.S. U.S./open system 8/7+ batch, random access/benchtop/rack 16 x 34 x 2 in/4 sq ft open system open system open system general biochemistries up to 12 min. strip, 8; max. full plate, 96 photometric, potentiometric, & Chemiflex (enhanced chemiluninescence) /5 1,7 8 hr/28 days/ /assay name, reagent No., lot No., tests per kit, expiration date, others open system/smartwash techlogy 3/367/>75, /liquid both disposable and semi-permanent glass/1,2 or 165 /as needed, 1-yr minimum 2 ul 5 ul / /3 L per hr 48-7 decibels /1 16 mm diameter, up to 75 1 mm height/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / <2 sec (to be available in next SW revision) 2 or 6 pt. /28 days / from 2 levels after calibration, to 3 to / //1 min EIA/coated microwell up to 12 27/ // (1 C below ambient) /ne /96/12 /liquid /96 / 2 µl 2µL/ / /12 x 75 mm/ / / / / / / / / shortest interval: each run; longest: daily / //2 min Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists <15.6 min <2 sec 4/1,2 / onboard/ all major LIS vendors (broadcast download & host query) //, Abbott Link 8 business hr 7.3 weeks/ daily: <1 min; weekly: <1 min / $375,/2 5 immuassay tests per day / integration of CC and IA without compromising stat TAT, results, or throughput, because of patented SmartWash techlogy, which minimizes carryover to <.1 ppm; large reagent capacity of 93 assays, with sample load up to 367; efficiency provided via multiple patented techlogies 3 sec / onboard/ (included) (broadcast download & host query) // within 48 hr / daily: <1 min; weekly: <1 min; monthly: <1 min / $25,/up to 5 tests per day $4, 3 days on site/ ability to perform general biochemistries CMYK Page 2 2

4 2 4 / CAP T O D A Y June 25 Automated immuassay analyzers Part 3 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Bayer Health Care Diagstics Division Denise Pastore denise.pastore.b@bayer.com 511 Benedict Ave. Tarrytown, NY ADVIA Centaur/1998/U.S. Ireland/U.S. >1,3/>3,1 cont. random access/floor standing/rack or direct track sampling 51.5 x 72.5 x 41.5 in/21 sq ft TSH, 3rd-gen. TSH, T4, FT4, T-uptake, T3, FT3, B12, fol., RBC fol., ferr., LH, FSH, prolac., progest., testost., estradiol, hcg, CK-MB, myogl., trop. I, digoxin, digitoxin, urine & serum cortisol, IgE, equimolar PSA, CEA, AFP, BR 27.29, tobramycin, carbamazep., phebarb., cpsa, phenytoin, atpo, gentamicin, theophylline, vancomycin, anti-tg, rubella IgG & IgM, toxo IgG & IgM, valporic acid, CA 15-3, ipth, homocys., CA 125 II, C-peptide, insulin, BNP, CA-19-9, HER-2/neu HBsAg, HBsAg conf., HIV1//2 specific allergens, mixes, allergy screen, HBsAg conf., HBsAg, HIVI//2 HBeAg, anti-hbe, cyclosporine, high-sensitivity troponin I, ANA, CMV IgG, CMV I g M ne cpsa, HER-2/neu Bayer Health Care Diagstics Division Maggie Bru maggie.bru.b@bayer.com 511 Benedict Ave. Tarrytown, NY ADVIA Centaur CP Immuassay System/available September 25/U.S. Germany/U.S. / batch, random access, continuous random access/benchtop/7 x 12 position racks 43 x 29 in/8.7 sq ft AFP*, CEA, cpsa*, PSA*, digoxin, BNP, CK-MB, C troponin I, homocysteine, myoglobin, E26III, FSH, LH, progesterone, prolactin, ThCG, FT4, FT3, T3, T4, TSM, TSM-3, T-uptake, ferritin, folate, RBC folate, VB12 * subject to permarket approval in U.S. CA 125, CA 19-9, CA 15-3, HER-2/neu, HIV 1//2, HCV, HBsAg, HBsAg conf, anti- HBS, HBc total, MBc total, HBc IgM, HAV total, HAV IgM, anti-tpo, anti-tg, cortisol, insulin, C-peptide, rubella G, rubella M, toxoplasma G, toxoplasma M, digitoxin, theophylline, phebarbital, phenytoin, carbamazipine, cyclosporine, valproic acid, vancomycin, gentamicin, tobramycin, HBeAg, anti-hbe, ANA cpsa, HER-2/neu chemiluminescence/magnetic particle 3 3 3/ hr/28 days/ (4 C) /assay name, lot No., expir., pack ID /zero carryover 23/18/84 /liquid /1, 1 µl, 1 µl/5 µl / /~2.5 L per hr <64 decibels w/in 1 meter /multiple/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 15 sec minimum 2 /varies, avg. 21 days / / //ne chemiluminescence/magnetic particle / hr/28 days/ (2 8 C) /reagent ID, lot No., expiration date /zero carryover 21/4/4 /liquid /4 1 ul 1 ul/5 ul / up to 65 decibels /multiple/ (2 of 5 interl., codaboar, codes 39 & 128)/ / / / / / 2 sec 2 / user defined / //<5 min Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists 18 min 15 sec 8/24 (15 sec) / onboard/ Cerner, Misys, Meditech, McKesson, Citation, Antrim, Soft, CCA, Dynamic Healthcare, Dawning, NLFC, DI, Triple G, and most other major vendors custom definable via LIS (broadcast download & host query) (IDS, Lab InterLink, Labotix, CLIDS, PSS, Hitachi CLAS, A&T) // 4 hr, max. / daily: 3 min; weekly: 2 min; monthly: 3 min / $225,/3+ beds or 4 tests per day $21,5 varies on site, 4 days at vendor offices/ ability to access/change solutions, waste, disposables and reagents at any time without pausing sampling or processing; onboard automatic dilutions, repeats, and cascade reflex testing; disposable tips; 24 results per hour, compatible with Hitachi racks; dedicated stat entry, smart algorithm 15.6 min <1 min 6/18 (2 sec) / onboard/ ADVIA Centaur CP is compatible with ADVIA Centralink Networking Solution (broadcast download & host query) // 4 hr, max. t available/t available daily: 3 min; weekly: 2 min; monthly; 3 min / $15,/community hospitals, satellite labs to be determined 4 days at vendor offices/ add reagents, consumables, samples without interuption; uses same reagents/consumables as ADVIA Centaur; throughput 18 tests/hour CMYK Page 2 4

5 2 6 / CAP T O D A Y June 25 Automated immuassay analyzers Part 4 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Beckman Coulter Inc. Joel Greiner jcgreiner@beckman.com 2 S. Kraemer Blvd. Brea, CA Access Immuassay System/1993/U.S., France U.S./U.S., France 1,5/2,5 Cont. random access/benchtop/rack 18.5 x 39 x 24 in/6.5 sq ft CEA, T3, T4, T-uptake, 3rd-gen. TSH, FT4, FT3, βhcg, DHEA-S, prolac, FSH, LH, progest., estrad., unconj. estriol, B12, fol., RBC fol., ferr., intrinsic factor Ab, CK- MB, myogl., cortisol, urine cortisol, insulin, AFP-open neural tube defect, total IgE, digox., theoph., chlam. Ag, urine chlam. Ag, chlam. Ag confirm., toxo IgG, rubella IgG, hybritech PSA & fpsa, testosterone, ostase, toxo IgM, antithyroglob., h y p e r- sensitive human growth hormone, thyroglobulin, AccuTnI, OV monitor (CA 125 antigen), BR monitor (CA 15.3 antigen), GI monitor (CA 19.9 antigen), BNP HIV 1/2, HBsAg, HBsAg confirm., HBsAB, HCV Ab, HAV Ab, HAV IgM, HBcAb, HBc IgM ne CMV IgG & IgM, rubella IgM, PTH, anti-tpo, EPO, soluble transferrin receptor, IL-6, B2-glycoprotein 1 Ab, ANA, anti-dsdna ne chlam. Ag & confirm., AFP-ONTD, hybritech PSA & fpsa, intrinsic factor Ab Beckman Coulter Inc. Joel Greiner jcgreiner@beckman.com 2 S. Kraemer Blvd. Brea, CA Access 2 Immuassay System/21/U.S. U.S./U.S. & France 1,/8 cont. random access/benchtop/rack 18.5 x 39 x 24 in/6.5 sq ft CEA, T3, T4, T-uptake, 3rd-gen. TSH, FT4, FT3, βhcg, DHEA-S, prolac, FSH, LH, progest., estrad., unconj. estriol, B12, fol., RBC fol., ferr., intrinsic factor Ab, CK- MB, myogl., cortisol, urine cortisol, insulin, AFP-open neural tube defect, total IgE, digox., theoph., chlam. Ag, urine chlam. Ag, chlam. Ag confirm., toxo IgG, rubella IgG, hybritech PSA & fpsa, testosterone, ostase, toxo IgM, antithyroglob., h y p e r- sensitive human growth hormone, thyroglobulin, AccuTnI, OV monitor (CA 125 antigen), BR monitor (CA 15.3 antigen), GI monitor (CA 19.9 antigen), BNP HIV 1/2, HBsAg, HBsAg confirm., HBsAB, HCV Ab, HAV Ab, HAV IgM, HBcAb, HBc IgM ne CMV IgG & IgM, rubella IgM, PTH, anti-tpo, EPO, soluble transferrin receptor, IL-6, B2-glycoprotein 1 Ab, ANA, anti-dsdna ne chlam. Ag & confirm., AFP-ONTD, hybritech PSA & fpsa, intrinsic factor Ab chemiluminescence/magnetic particle /5 tests per cartridge, 1 tests per kit 336 hr/28 days/ (4 C) /assay No., lot No., expir., unique reag. pack ID No. / 1 ppm 18/6/3-31 /liquid /294 specimen container dependent 5 µl/1 µl / / <7 decibels /13 x 75 & 1, 16 x 75 & 1, 2 ml & 3 ml sample cups/ / / / / / / 6 /28 days / / //remains in ready mode chemiluminescence/magnetic particle /1 tests per kit, 5 tests per cartridge 336 hr/28 days/ (4 C) /assay No., lot No., expir., unique reagent pack ID No. / 1 ppm 18/6/3 /liquid /294 specimen container dependent 5 µl/1 µl (when networked)/ <7 decibels /1 µl /13x75 & 1, 16x75 & 1, 2 µl & 3 µl cups; 13x75, 13x1 aliquot tubes/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 36 sec 6 /28 days / / //remains in ready mode Modem servicing/can diagse own malfunctions/determine 15 min 36 sec 33/1 (36 sec) / onboard/ (included or addt l costnegotiable) all major LIS vendors (host query) // max., usually w/in 6 hr t available/t available daily: 15 min; weekly: 3 min; monthly: ne / $129,8/all vols. & hospital sizes $14, 8 4 days at vendor offices/ continuous random access benchtop analyzer; state-of-the-art chemiluminescence methodology; ease of use: any test, any tech, any time; superior assays: TSH, FT 4, UE 3, hybritech PSA, fpsa, B 12, fol., AccuTnI 15 min 36 sec 33/1 (36 sec) / onboard/ (included or additional costnegotiable) all major LIS vendors (broadcast download & host query) // max., usually within 6 hr TBD/TBD daily: 15 min; weekly: 3 min; monthly: ne / $149,8/all volumes & hospital sizes $15,8 4 days at vendor offices/ ability to network up to four Access 2s using a single LIS interface with remote diagstics, fully automated user-defined reflex testing; onboard context sensitive help, aliquot tube capability; continuous random access benchtop analyzer; state-of-the-art chemiluminescence methodology; superior assays: TSH, FT 4, UE 3, hybritech PSA, fpsa, B 12, fol., AccuTnI Tabulation does t represent an endorsement by the College of American Pathologists CMYK Page 2 6

6 2 8 / CAP T O D A Y June 25 Automated immuassay analyzers Part 5 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Beckman Coulter Inc. Katie Blount 2 S. Kraemer Blvd. Brea, CA Synchron LXi 725/22/U.S. U.S./U.S. / cont. random access/floor standing/rack-closed tube 6 x x 48 in/44.8 sq ft CEA, T3, T4, TU, 3rd gen TSH, FT4, FT3, βhcg, DHEA-S, prolac, FSH, LH, progest, estrad., unconj. estriol, B12, fol., ferr., intrinsic factor Ab, CK-MB, myogl., cortisol, urine cortisol, insulin, AFP-open neural tube defect, total IgE, digox., theoph., chlam. Ag, urine chlam. Ag, chlam. Ag confirm, toxo IgG, toxo IgM, rubella IgG, hybritech PSA, hybritech fpsa, testosterone, thyroglob., anti-thyroglob., human growth hormone, ostase, AccuTnI, C3, C4, haptoglobin, BNP, OV monitor (CA 125 antigen), BR monitor (CA 15.3 antigen), GI monitor (CA 19.9 antigen), plus >1 Synchron chem tests, including critical care, general, esoteric, urine & CSF chemistries, all current Synchron DATs, TDMs, proteins, serologies CMV IgG & IgM, rubella IgM, PTH, anti-tpo, EPO, soluble transferrin receptor, IL-6, B2-glycoprotein 1 Ab, ANA, anti-dsdna only system to perform heterogeneous immuassays & general chemistry on a single platform using closed tube sampling Beckman Coulter Inc. Joel Greiner jcgreiner@beckman.com 2 S. Kraemer Blvd. Brea, CA UniCel DxI 8/23/U.S. U.S./U.S., France 3/3 cont. random access/floor standing/rack, direct track sampling 66.7 x 67.5 x 37.7 in/17.7 sq ft CEA, T3, T4, T-uptake, 3rd-gen. TSH, FT4, FT3, βhcg, DHEA-S, prolac, FSH, LH, progest., estrad., unconj. estriol, B12, fol., RBC fol., ferr., intrinsic factor Ab, CK- MB, myogl., cortisol, urine cortisol, insulin, AFP-open neural tube defect, total IgE, digox., theoph., chlam. Ag, urine chlam. Ag, chlam. Ag confirm., toxo IgG, rubella IgG, hybritech PSA & fpsa, testosterone, ostase, toxo IgM, antithyroglob., h y p e r- sensitive human growth hormone, thyroglobulin, AccuTnI, OV monitor (CA 125 antigen), BR monitor (CA 15.3 antigen), GI monitor (CA 19.9 antigen), BNP HIV 1/2, HBsAg, HBsAg confirm., HBsAB, HCV Ab, HAV Ab, HAV IgM, HBcAb, HBc IgM CMV IgG & IgM, rubella IgM, PTH, anti-tpo, EPO, soluble transferrin receptor, IL-6, B2-glycoprotein 1 Ab, ANA, anti-dsdna ne chlam. Ag & confirm., AFP-ONTD, hybritech PSA & fpsa, intrinsic factor Ab chemiluminescence/magnetic particle /5 tests per cartridge, 1 tests per kit (immu), 3 tests per container set (general) 336 hr/28 days/ (4 C) /assay No., lot No., expir., unique reagent pack ID / 1 ppm 18/132/5,28 /liquid /294, 2 yr warranty (general chem.) 5 µl/1 µl / / / /13x75 & 1, 16x75 & 1 mm/ (2 of 5 interl., codabar, codes 39 & 128)/ / / for general chemistry/ for general chemistry / / 36 sec 6 /28 days / / //remains in ready mode chemiluminescence/magnetic particle 5 5 5/5 tests per cartridge, 1 or 1, tests per kit 336 hr/28 days/ (3 1 C) /assay No., lot No., expir., unique reagent pack ID No. /< 1 ppm 288 (avg.assay mix dependent)/12/1,2 (avg.) /liquid />1, specimen container dependent 5 µl/16 µl (PC only)/optional / <6 decibels /1 µl /12x75 to 16x1 mm/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / <9 sec (min.) /28 days / 24 h / //remains in ready mode Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists 17 min 36 sec 33/1 (36 sec) / onboard/ (included or additional cost is negotiable) (broadcast download & host query) // max., usually within 6 hr / / / / workstation consolidation without compromise through the use of invative automation; single point-of-sample entry using closed tube sampling, dual scheduling, and parallel processing with full menu equivalence to the Synchron and Access product lines 15 min 18 sec min. 67, max. 133/min. 2, max. 4 (9 or 18 sec) / onboard/ (included or additional cost is negotiable) all major LIS vendors (broadcast download & host query) (Beckman Coulter automation systems) // per negotiated contract / daily: <1 min; weekly: TBD; monthly: ne / $325,/3+ beds or >4 tests per day $29,9 5 days at vendor office for 2 employees/ highest throughput immuassay analyzer; uses proven chemiluminescent assay techlogy and reagent packs to deliver consistent results with other Access systems; allows operators to load consumables on the fly without interacting with system console; stores sample aliquot onboard CMYK Page 2 8

7 3 / CAP T O D A Y June 25 Automated immuassay analyzers Part 6 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers The Binding Site Inc. Gary Tremain gary.tremain@thebindingsite.com 5889 Oberlin Dr., #11 San Diego, CA DSX Automated System/2/Guernsey, U.K. U.S./U.K. >15/>5 batch/benchtop/rack 32 x 42 x 36 in/7 sq ft ANA screen, ENA scr., SS-A, SS-B, Sm, Sm/RNP, Jo-1, Scl-7, dsdna, GBM, MPO, PR3, TG, TPO, cardiolipin IgG/IgM/IgA & scr, B2GP1 IgG/IgM/IgA & scr, phosphatidylserine IgG/IgM/IgA, C1q CIC, gliadin IgG/IgA & scr, ttg IgA, ttg IgG, RF, anti-ccp, histone, EBV VCA IgG/IgM, EBV EA-D IgG, EBV EBNA-1 IgG/IgM, toxo IgG/IgM, rubella IgG/IgM. CMV IgG/IgM.IgM capture, HSV 1/2 IgG, measles IgG/IgM, mumps IgG, VZV IgG, IgM, lyme IgM/IgG & scr, H. pylori, syphilis, chlamydia, mycoplasma, legionella IgG/IgM, legionella UA, CCP, HSV 1/2 IgG type specific ne t. tox, ASCA IgG/IgA open systemany ELISA open system phosphatidylisitol IgG/IgM/IgA, phosphatidylethalamine IgG/IgM/IgA, phosphatidylglycerol IgG/IgM/IgA, phosphatidylcholine IgG/IgM/IgA, phosphatidic acid IgG/IgM/IgA, prothrombin, C3d CIC, SMA, LKM open system open system min. strip 1 x 8; max. full plate 96 x 4 plates biomérieux Inc. Vincent Tumminello vincent.tumminello@na.biomerieux.com 1 Rodolphe St. Durham, NC Vidas & MiniVidas/1989/U.S. Italy/France 2,2/>2, batch, random access/benchtop/ Vidas: 16 x 32 x 21 in; MiniVidas: 21 x 21 x 17 in/vidas 4.5, MiniVidas 4 sq ft same for both instruments: C. diff. toxin A, chlam. Ag, chlam. blocking, rotavirus, rubella IgG, measles IgG, mumps IgG, varicella IgG, Lyme (IgG/IgM), TSH, FT4, T4, T3, hcg, estradiol, FSH, LH, prolac., progest., ferr., cortisol (serum & urine), total IgE, digoxin, H. pylori IgG, toxo IgG, toxo IgM, CMV IgG, CMV IgM., quant. D- dimer, tpsa, toxo competition, testosterone myoglobin, trop. I HBsAg, anti-hbs total, anti-hbc IgM, anti-hbc total, HBeAg, anti-hbe, HAV IgM, anti-hav total, HIV 1/2, HIV P24II, HIV DVO, tox IgG avidity, testosterone, myoglobin, trop. I, FT3, fpsa, CEA, AFP, CA 15.3, CA 19.9, CA 125, vwt, prot. C, β-2-microglobulin, stallergy ne EBV, HbA1c ne all assays for use on Vidas instruments only 1 test per strip EIA/coated microwell 12 assays per plate 25/96 per 4 plates // requires operator prehandling/preparation / /92/ /liquid 2 µl 5 µl/2 µl (5 µl with microtubes) / /5 µl /various/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / assay specific /once per analyte per plate / per plate / //1 2 min fluorescence, EIA/coated solid phase receptacle (SPR)/pipetting device Vidas: 3, MiniVidas: 12 total menu unit dose format/3 or 6 // /assay name, lot No., sequence No., expir. /zero carryover /12 3/12 3 /dry 1 µl 1 µl/ / / // (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 1 /14 days (mftr.-determined calib. curves)/ shortest interval: 8 hr, longest: / //remains ready Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists / onboard/ (additional) Cerner, Misys (host query) (manual transmission available) // within /< daily: 5 min; weekly: ; monthly: / $49, (dependent on modules)/2+ beds $7,95 3 days on site, 2 days at vendor offices/ fully open, true four-plate system, modular design of reader, washer, incubators, bar-code reader and ambient drawer enables easy upgrades and express shipping of replacement modules reducing downtime; software can be trained for learned error recovery 3 min delay Vidas: 2, MiniVidas: 8/Vidas: 6, MiniVidas: 24 () / onboard/ (addt l cost) Misys, Meditech, McKesson, Advanced Lab Systems (Path Lab), Cerner, Citation, SCC, Siemens, SAIC/CHCS, CompuLab, Antrim, Dawning, Genesys (Dynamedix), others (broadcast download) // w/in Vidas: 35 days, MiniVidas: 1, days/<2 hr daily: 1 15 min;, weekly: 1 15 min; monthly: 3 min / Vidas: $51,8, MiniVidas: $28,1/ 4 beds $2,34 $4,68 (MiniVidas 3) as needed on site, 3 days at vendor offices/ unique dual-function combination solid phase & pipetting device (SPR); assay menu mix (antigen detection, serology, fertility, thyroid, endocrine, coagulation) makes Vidas the ideal instrument for routine batch testing as well as emergency stat testing CMYK Page 3

8 3 2 / CAP T O D A Y June 25 Automated immuassay analyzers Part 7 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Bio-Rad Laboratories Clinical Diagstics Group 4 Alfred Nobel Dr. Hercules, CA Coda/outside U.S. 1996; in U.S. 1997/Japan Japan/U.S., U.K., France, Korea, Australia 6/55 batch/benchtop/rack 21.6 x 39.5 x 26 in/7.13 sq ft contact Bio-Rad representative contact Bio-Rad representative biotinidase, leucine, IRT, TSH, PICU, TGAL, GALT, 17HP Bio-Rad Laboratories Clinical Diagstics Group 4 Alfred Nobel Dr. Hercules, CA PhD System/2/Belgium Belgium/U.S. 15/25 batch/benchtop/rack 35 x 66 x 35 in/16 sq ft ANA (EIA), anti-centvomere (EIA), anti-dsdna (EIA), anti-ena (EIA), anti-jo-1 (EIA), anti-ss-a (EIA), anti-ss-b (EIA), anti-scl-7 (EIA), anti-sm (EIA), anti- SmRNP (EIA), anti-ssdna (EIA), acl IgM, acl IgG, acl IgA, anti-β2gpi IgG, antiβ2gpi IgM, anti-β2gpi IgA, aps IgG, aps IgM, aps IgA Tests t available on other manufacturers analyzers STC drugs of abuse, Ostex Ntx, DSL assayscontact companies represented min. strip: 1 sample; max. full plate, 96 1 min. strip: 1; max. full plate: 96 EIA/coated microwell & ncoated microwell assays, 24 containers/288 tests // requires operator prehandling/preparation /reduced w/software version 4. & updated firmware, depends on amount of washing varies by assay/9-27/up to 9 /liquid, reconst. onboard ( for dils.) 1 µl specimen out of 11 µl 1 µl/2 µl, 13 µl in microtubes optional/ / /13 µl t claimed, but some users have validated for their own use/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 1 6 /most assays require calib. w/ each run, some as long as 2 weeks w/ 1 & 2 pt. updates / shortest interval: user determined, longest: w/in run recommended / (late 2 through Unity QC program) for hardware/6 min EIA/coated microwell 8 8 limit 8/192 4 hr// requires operator prehandling/preparation / / 195/184/1 /liquid / / 1 µl specimen 1 µl/2 µl / // (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 1 5 /each run / each run / //5 min Modem servicing/can diagse own malfunctions/determine ~9 tests per hr w/ all results in approx. 3 hr ()/ (protocol specific) / (t yet tested) onboard/customer acquires through LIS company, can be added to contract homegrown systems, Cerner, Dawning, & Sunquest in development t possible on batch analyzer can be customized (broadcast download) // /4 hr daily: 5 min; weekly: 2 min; monthly: 2 min / $48,/5 35 beds, 4 6 plates per days $4,8 as needed on site, 3 days at vendor offices/ Coda 4. adds powerful, new fluidic controls, dilution capabilities, audible alarms, and new wash parameters; able to perform pretreatment of sample (pipette, incubate, transfer to coated well); five methods for creating sample dilutions; easy-to-operate programming / / onboard/ (included) can be customized // < 6 months/4 hr daily: 15 min; weekly: 15 min; monthly: 3 min / $38,/>5 tests per day $6, 2 days on site/ accurate pipetting at 1 µl; connection of 1 1 pipetting stations together through an ethernet hub, graphical user interface; added module for IFA slide processing Tabulation does t represent an endorsement by the College of American Pathologists CMYK Page 3 2

9 June 25 C A P TODAY / 3 3 Automated immuassay analyzers Part 8 of 22 Tests cleared but t clinically released Bio-Rad Laboratories Clinical Diagstics Group 4 Alfred Nobel Dr. Hercules, CA Evolis/21/Germany Germany/U.S. 1/25 batch/benchtop/rack 37 x 44 x 3 in/1 sq ft contact Bio-Rad representative Dade Behring Inc. P.O. Box 611 Newark, DE Stratus CS Stat Fluorometric Analyzer/1998/U.S. U.S./U.S. 7/7 random access/benchtop/whole blood collection tube 18 x 27 x 22 in./4.1 sq. ft. mass CK-MB, trop. I, myoglobin, β-hcg, D-dimer, NT-pro BNP Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers HIV Ab, HIV Ab/Ag, HIV Ag, HBsAg, HBc Ab, HCV Ab, HTLV-1, anti-hbs, toxo IgG, toxo IgM, rubella IgG, EBV VCA IgG, EBV VCA IgM, EBV EAD, EBV EBNA, syphilis total Ab, CMV total Ab t in U.S. infectious disease & autoimmune panels ne ne min. strip, 1; max. full plate, 96 EIA/coated microwell 4 4 closed in U.S. market 4/96 3 missay dependent/ / (disposable tips) varies by assay/18/4 /liquid microplates microplates.2 µl 1 µl/1 µl / 6 decibels /5, 7, 1 ml/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / /with each run / user determined / (through Unity QC program) / fluorescence, EIA, dendrimer techlogy/fiber matrix filter up to 4 1 /unit dose test packs /assay ID, lot No., expir., calib. param. /zero carryover 14 min to 1st result, subsequent results in 4 min intervals/1/up to 4 /liquid 2.5 ml whole blood / / <65 decibels /4 or 5 ml/ (2 of 5 interl., codabar, codes 39 & 128)/ / / t affected / / 1 cal pack /3 9 days same lot, new lot / shortest interval: daily electronic QC, longest: every 3 days for liquid controls / //3 min. to warm up Modem servicing/can diagse own malfunctions/determine / onboard/ in development (broadcast download) // / daily: 5 min; weekly: 1 min; monthly: 3 min / $65,/5 4 tests per day inquire 3 days in Redmond, Wash./ fully automated microplate system that meets the highest level of safety (positive identification of samples, reagents, microplates, clot detection, contamination), flexibility (continuous loading of samples, reagents, and microplates), and productivity (four plates, 18 samples, four different assays can be processed simultaneously) 14 min immediately 3/9 / / (additional) all major LIS vendors // 2 8 hr >225 days/2.9 hr daily: ne; weekly: ne; monthly: 1 min / /any size emergency department multiple types 3 days on site/ whole blood collection tubes (heparin) or precentrifuged plasma (heparin); onboard centrifugation; unit-dose test packs; color-coded calibrators packaged on Calpaks; diluent packs for dilutions; self-contained system ( waste lines, water, etc.); closed container sampling; electronic QC; POCT1-A compliant when interfaced to Telcor or MAS Data Managers Tabulation does t represent an endorsement by the College of American Pathologists CMYK Page 3 3

10 3 4 / CAP TODAY June 25 For more information from MP Biomedicals, circle No. 84 on card Automated immuassay analyzers Part 9 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Dade Behring Inc. P.O. Box 611 Newark, DE Dimension Xpand Plus Integrated Chemistry System/21/U.S. U.S./U.S. 1,2/8 random access, cont. random access/floor-standing/racks 45 x 51 x 31 in (without monitor)/1.6 sq ft thyrox. uptake, total thyrox., hemoglobin A1c, acid phosphat., alanine amitransferase, alkaline phosphatase, amylase, aspartate amitransferase, CK, CK isoenzyme, glutamyl transferase, lactic dehydrogenase, lipase, pseudocholinesterase, ferr., free thyrox., HCG, mass CK-MB, myoglob., tpsa, fpsa, TSH, trop. I, C3, C4, CRP, high-sens. CRP, IgA, IgG, IgM, transferr., ammonia, urine CSF protein, lactic acid, prealbum., carbamazep., cyclosporine, digox., digitox., gentamicin, lithium, phebarbital, phenytoin, theophy., tobramycin, vancomycin, valp. acid, acetamiphen, ethyl alcohol, salicylate; urine screens: amph., barbit., benzo., cannab., cocaine metab., methad., opiates, phencyc., procainamide, lidocaine, n-acetylprocainamide (see Dimension RxL Max for full general chemistry menu), quinidine, triiodothyronine, microalbumin, NT-proBNP system performs heterogeneous immuassays and general assays on single platformcomplete routine chemistry menu Dade Behring Inc. P.O. Box 611, Newark, DE Dimension RxL Max/Max Suite Integrated Chemistry System/23/U.S.; Dimension RxL Integrated Chemistry System/1997/U.S. U.S./U.S. combined: 2,5/2, batch, random access, cont. random access/floor-standing/racks 44 x 62.5 x 3.5 in./13.2 sq ft See Dimension Xpand test menu for endocrilogy, enzymes, heterogeneous immuassays, specialty, immulogy, TDM & toxicology. General chemistry test menu: album., calcium, cholest., creatinine, dir. & total bili., enzymatic CO2, glucose, HDLC, automated HDL, automated LDL, iron, magnes., phosphorus, total iron-binding capacity (& pretreat), total protein, triglyc., urea nitrogen, uric acid, carbon dioxide, chloride, potassium, sodium system performs heterogeneous immuassays and general assays on a single platformcomplete routine chemistry menu EIA, latex particle turbidimetric, direct turbidimetric/heterogeneous, magnetic particles / hr/3 days/ (2 8 C) /lot No., unique flex ID, stability, expiration date / due to probe washing can be hours/6/>1, /reconstitutes onboard, reagent prep required by operator for liquid /12, / 2 µl 2 µl/primary tube capable / /up to 2 L per hr <7 /1 2 µl /5, 7, 1 ml/ (2 of 5 interl., codabar, codes 39 & 128)/ / (HM)/ / / / <2 sec varies3 levels for most assays (Na, K, Cl)/up to 9 days / / t required EIA, latex particle turbidimetric, direct turbidimetric/heterogeneous, magnetic particles 47 (91 with optional reagent management system) 19 1 Max=47, Max Suite=91/ hr/3 days/ (2 8 C) /lot No., unique flex ID, stability, expiration date / due to probe washing can be hours/6/>1, / reagent prep required by operator for liquid /12, / 2 µl 2 µl/primary tube capable / /3.2 L per hr <7 /1 2 µl /5, 7, 1 ml/ (2 of 5 interl., codabar, codes 39 & 128)/ / (HM)/ / / / <2 sec varies3 levels for most assays (Na, K, Cl)/up to 9 days / / t required Modem servicing/can diagse own malfunctions/determine 16 min 24 sec 83/25 (14.4 sec) / optional/ (additional) all major LIS vendors (broadcast download & host query) // 2 8 hr / daily: <5 min; weekly: 1 min; monthly: 15 min / / multiple types 5 days on site; 4 days at vendor offices/ consolidated low-volume workstation that integrates immuassays onboard with other chemistries; allows single platform to meet over 95 percent of testing needs; eliminates sample splitting, aliquotting 16 min 24 sec /167 5 (7.2 sec.) / optional (DBNet Dade Behring)/ (addt l cost) all major LIS vendors (broadcast download & host query) // 2 8 hr / daily: 5 min, weekly: 1 min, monthly: 15 min / / multiple types 5 days on site, 4 days at vendor offices/ analyzer integrates heterogeneous immuassays onboard with other chemistries; allows single platform for over 95 percent of most requested tests; eliminates sample splitting between general tests and immuassays Tabulation does t represent an endorsement by the College of American Pathologists CMYK Page 3 4

11 June 25 C A P TODAY / 3 5 Automated immuassay analyzers Part 1 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Diagstic Products Corp. Joe Kelly info@dpconline.com 521 Pacific Concourse Dr., Los Angeles, CA IMMULITE/1993; IMMULITE Turbo/1999; IMMULITE 1/22/U.S. U.S./U.S., U.K. >6,3 worldwide cont. random access/benchtop/loading platform 19 x 46 x 26 in/7.98 sq ft AlaTOP allergy scr., total IgE, EPO, ferr., fol. acid, B12, intact PTH, Pyrilinks-D, carbamazep., phenytoin, valp. acid, phebarb., CMV IgG, herpes I & II IgG, rubella IgG quant., toxo IgG quant., DHEA-SO4, estrad., unconj. estriol, FSH, hcg, LH, progest., prolac., testost., digitox., digox., theoph., anti-tg Ab, anti-tpo Ab, FT3, FT4, rapid TSH, TBG, 3rdgen. TSH, T-uptake, TT3, TT4, thyrogl., AFP, CEA, OM-MA, PAP, PSA, 3rd-gen. PSA, canine TT4 & TSH, C-pep., insul., CK-MB, myogl., trop. I, ACTH, β-2-microgl., cortisol, HsCRP, hgh, rubella IgM, toxo IgM, SHBG, homocysteine, H. pylori IgG, Turbo menu: C K - MB, myoglob., intact PTH, trop. I, hcg, HBsAg, HBsAg confirm, BR-MA (CA 15-3) (contact company for full menu) ne ne GI-MA (CA 19-9), free PSA, TPS, nicotine metabolite, cytokines, free βhcg, IL-6, IL-8, IL-1, LBP, PAPP-A A N A scr., celiac markers, CMV IgM, D-dimer (Turbo), dsdna Ab, EBV-EA IgG, EBV- EBNA IgG, EBV-VCA IgG, EBV-VCA IgM, gastrin, anti-hav total & IgM, HBeAg, anti- HBe, HSV I/II IgG, Lyme screen, NT-proBNP, syphilis, canine & feline TL1, vit. D ne 3rd-gen. PSA, AlaTOP allergy screen, allergy food panel FP5E, SHBG, TBG, EPO, canine TSH, thyroglob., intact PTH, ACTH. Turbo: intact PTH Diagstic Products Corp. Joe Kelly info@dpconline.com 521 Pacific Concourse Dr., Los Angeles, CA IMMULITE 2/1998/U.S. U.S./U.S., U.K. >3,6 worldwide Cont. random access/floor-standing/rack 47 x 6 x 3 in/12.5 sq ft AlaTOP allergy scr., 3gAllergy (>36 specific allergens & allergy panels; includes test for animals, drugs, dust, foods, grasses, insects, mites, molds, occupational, parasites, trees, weeds), total IgE, EPO, AFP, CEA, OM-MA (CA 125), PSA, 3rd-gen. PSA, FT3, TT3, FT4, TT4 TBG, thyrogl., anti-tg Ab, anti-tpo Ab, T-uptake, rapid TSH, 3rd-gen. TSH, DHEA-SO4, estrad., FSH, hcg, LH, progest., prolac., total testost., β-2-microgl., cortisol, ferr., intact PTH, C-pep., folic acid, B12, insulin, unconj. estriol, carbamazep., phenytoin, valp. acid, HsCRP, hgh, ACTH, PAP, phe, homocysteine, CMV IgG (qualit)., H. pylori IgG, rubella IgG, toxo IgG, troponin I, CK-MB, herpes I & II IgG, ALA top allergy screen, Pyrilinks-D, myoglobin, toxo IgM, canine TSH, rubella IgM, digoxin, GENT (contact company for full menu) ne ne GI-MA (CA 19-9), fβhcg, IL-6, nicotine metabolite, PAPP-A, fpsa ECP A N A scr., celiac markers, CMV IgM, D-dimer, dsdna Ab, EBV-EA IgG, EBV-EBNA IgG, EBV-VCA IgG/IgM, gentamicin, anti-hav total & IgM, HBeAg, anti-hbs, H S V I/II IgG, allergen-specific IgG & IgG4, IL2R, LBP, Lyme screen, NT-proBNP, osteocalcin, syphilis, canine & feline TL1, vancomycin, vit. D ne TBG, thyrogl., SHBG, intact PTH, C-peptide, 3rd-gen. PSA chemiluminescence/bead, centrifugation 12; Turbo: 5 ; Turbo: 5 12/1; Turbo: 5 for intact PTH only /3 days/ (15 C) /test, lot No., expir. /<1 ppm 1//7 /liquid / 5 µl 5 µl/1 µl / /.5 L per h 55 min., max. 68 // (2 of 5 interl., codabar, codes 39 & 128)/ / / / / 2-level adjustors, supplied in kit /1 4 weeks (); Turbo: 2 weeks / customer determined / //5 min chemiluminescence/bead, centrifugation 24 24/2 /9 days/ (4 C) /test, lot No., expir. /<3 ppm 3/9/1,3 /liquid /1,3 5 µl to 1 µl sample 5 µl/5 µl / / 52 decibels /5 µl /75 1 mm height; mm width/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / min. 18 sec 2 level adjustors, supplied in kit /1 4 weeks () / cutomer determined / //4 min Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists 42 min; Turbo: 15 min 2.5 min 12/12 () / onboard/ (addt l cost) CIS, CPSI, CCA, Mysis, McKesson, Cerner, Antek, CSS, others (broadcast download & host query) // 4 hr 11 mos/4 hr daily: 5 min; weekly: 1 min; monthly: 2 min / $75,; Turbo: $77,5/>1, tests per month $8, 3.5 days at vendor offices/ system performance reliability; worldwide user satisfaction; breadth of immuassay menu 35 min 18 sec 2/2 (18 sec) / onboard/ (additional cost) Antek, Cerner, CIS, CPSI, CSS, CCA, LabSoft, Meditech, McKesson, Mysis, SCC, others (broadcast download & host query) (universal interface) // 4 hr 3 mos/5 hr daily: 5 1 min; weekly: 2 min; monthly: 2 3 min / $124,5/>4, tests per month $14,5 varies on site, 5 days at vendor offices/ high throughput system with Windows-based, fully multitasking software; integrated training via tutorial and interactive training CD series; clot detection; sample/reagent level detection; auto dilutions and auto reflex testing; remote diagstics CMYK Page 3 5

12 3 8 / CAP T O D A Y June 25 Automated immuassay analyzers Part 11 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Diagstic Products Corp. Joe Kelly info@dpconline.com 521 Pacific Concourse Dr., Los Angeles, CA Immulite 25 SMS/24/U.S. U.S./U.S., U.K. see IMMULITE 2 continuous random access/floor standing/rack 79 x 112 x 4 in/3.69 sq ft cortisol, AlaTOP, 3rd gen allergen-specific IgE, 3gAllergy (>36 specific allergens & allergy panels; includes tests for animals, drugs, dust, foods, grasses, insects, mites, occupational, parasites, trees, weeds) total IgE, ferritin, EPO, calcitonin, pyril. D, homocy., hscrp, insulin, C peptide, urin. albumin, IGF 1, hcg, CMV IgG, rubella IgG/IgM, toxoplasma IgG/IgM, H. pylori IgG, AFP, androstenedione, DHEA SO4, estrad., unconj. estriol, FSH, LH, prolactin, progesterone, testosterone, SHBG, CK-MB, HCG, stat troponin I, myoglobin, carbamazepine, digoxin, phenytoin, pheobarbital, theophylline, valp. acid, ACTH, β-2-micro., calcitonin, TB, anti-tg Ab (contact company for full menu) n o n e ne GI-MA (CA 19-9), fβhcg, IL-6, gastrin, PAPP-A, fpsa, anti-hbc, anti-hbc IgM, HBsAg & confirm, anti-hbs ne ANA scr., CMV IgM, D-dimer, digitoxin, dsdna Ab, EBV-EA IgG, EBV-EBNA IgG, EBV-VCA IgG, EBV-VCA IgM, fol. acid, gentamicin, anti-havigm, anti-hav total, HBeAg, anti-hbe, HSV I/II IgG, IGFBP-3, LBP, Lyme screen, NT-proBNP, osteocalcin, stat PTH, Pyrilinks-D, syphilis scr., tobramycin, vancomycin, B12, vit. D n o n e Diamedix Corp. Pat Ahmad pat_ahmad@ivaxdiagstics.com 214 North Miami Ave., Miami, FL or Mago Plus Automated EIA Analyzer/1997/Italy Italy/U.S. / Batch, random access/benchtop/2 racks, 12 samples total 28 x 48 x 26 in/8.7 sq ft, incl. onboard computer, reagents, spectrophotometer Autoimmune: anti-ssa/ro, anti-ssb/la, anti-sm, anti-sm/rnp, anti-scl-7, anti- Jo-1, anti-dsdna, RF, ENA-6 scr., ANA ELISA scr., anti-mpo, anti-pr-3, anti-tpo, anti-tg, anti-cardio. scr., anti-cardio. IgG, IgM, IgA, anti-β-2-glycopr. IgG, IgM, anti-gliadin IgG & IgA; Infectious: toxo IgG, toxo IgM capture, rubella IgG, rubella IgM capture, CMV IgG, CMV IgM capture, HSV I & II IgG & IgM, measles IgG, VZV IgG, EBV-VCA IgG & IgM, EBNA-1 IgG & IgM, EBV-EA-D IgG & IgM, anti-b. burgdorferi IgG/IgM, mumps IgG, H. pylori IgG, syphilis Trep-Chek, mycoplasma IgG & IgM, HSV 1 IgG, HSV 2 IgG n o n e n o n e all products available in the U.S. plus allergy tests (total and specific IgE) and a variety of additional kits for infectious and autoimmune diseases; please contact company for a complete international listing n o n e ttg IgA, CCP, C. diff. A&B, measles IgM, mumps IgM varied programs by customer at customer location assays designed/fda cleared for this analyzer; tests can be validated on other anals. usually 1 analyte per well; multiple analytes per well in screen tests min. strip: 8 or less (breakapart wells), max. full plate: 96, up to 4 plates simul. chemiluminescence/bead, centrifugation 24 24/2 /9 days/ (4 C) /test, lot No., expiration /3 ppm 3/9/1,3 /liquid /1,3 5 µl to 1 µl sample 5 µl/5 µl / / 52 decibels /5 µl /75 1 mm height; mm width/ (2 or 5 interl., codabar, codes 39 & 128)/ / / / / min. 18 sec 2 level adjustors, supplied in kit /1 4 weeks () / customer determined / //4 min EIA/microtiter 9 ~5 tests preprogrammed, ready for use 2 9/96 >16 h/6 days/ available/kit lot No., expir. date /t susceptible to carryover, has continuous internal cleaning varies from 15 min 24 min/9 tests & 384 results per run /liquid /12 / 5 µl in pediatric tube 4 µl/1 µl / / insignificant possible can use 1.5 ml vial/1 µl /up to 16 x 1/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / varies: 2 (single point curve tests), 6 (6 pt. curve tests), 3 (3 pt. curve tests) /every run / each run / //<5 min Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists 15 min 18 sec 2/2 (18 sec) / onboard/ (additional cost) Antek, Cerner, CIS, CPSI, CCS, CCA, LabSoft, Meditech, McKesson, Mysis, SCC, others (broadcast download & host query) (universal interface) // 4 hr 2 months/5 hr daily: 5 1 min; weekly: 2 min; monthly: 2 3 min / $2, includes SMS & RTS/2+ beds $19,5 varies on site, 5 days at vendor offices/ large automated immuassay test menu available; 15 minute stat assays, flexible sample handling, user-definable testing; runs specific allergen testing alongside routine immuassays; flexible connectivity to automation via the SMS; auto reflex, auto dilute; remote diagstics; RealTime Solutions (RTS) Internet-based service and support system <15 min set-up time 12/36 (~4 h) / onboard/ Cerner, Misys, Sunquest, others (LIS at hospital site, addt l cost) (broadcast download & host query) // w/in / daily: 3 min; weekly: 5 min; monthly: ne / (tracking of usage time for PM service) $62,/all bed sizes, all test volumes service during business hours included in reagent rental 1 2 days at vendor s facility or on site/as needed only system (reagents & instrument) FDA cleared; moderate complexity rating; automation-ready reagents and containers; user-friendly SW for rapid training; built-in safeguards to prevent aborted runs CMYK Page 3 8

13 4 / CAP T O D A Y June 25 Automated immuassay analyzers Part 12 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Diamedix Corp. Linda Schwartz linda_schwartz@ivaxdiagstics.com 214 N. Miami Ave. Miami, FL Parsec System/25/Italy Italy/U.S. / continuous random access/benchtop/racks 36 x 58 x 29 in/11.6 sq ft autoimmune: anti-ssa/ro, anti-ssb/la, anti-sm, anti-sm/rnp, anti-scl-7, anti- Jo-1, anti-dsdna, RF, ENA-6 scr., ANA ELISA scr., anti-mpo, anti-pr-3, anti-tpo, anti-tg, anti-cardio. scr, anti-cardio. IgG, IgM, IgA, anti-β-2-glycopr. IgG, IgM, anti-gliadin IgG & IgA; infectious: toxo IgG, toxo IgM capture, rubella IgG, rubella IgM capture, CMV IgG, CMV IgM capture, HSV I & II IgG & IgM, measles IgG, VZV IgG, EBV-VCA IgG & IgM, EBNA-1 IgG & IgM, EBV-EA-D IgG & IgM, anti-b. burgdorferi IgG/IgM, mumps IgG, H. pylori IgG, syphilis Trep-Chek, mycoplasma IgG & IgM, HSV 1 IgG, HSV 2 IgG, anti-hav ne ne allergy tests (total and specific IgE), anti-ra/ccp, anti-asca IgG/IgA, anti-annexin V, anti-prothrombin-iga, anti-ama-m2, anti-histone, HBsAg, HBs confirm., anti-hbs, anti-hbc (total), anti-hbc IgM, HBeAg, anti-hbe, anti-hav IgM, HCV, AB AU STD SET plus, HIV tests, anti-coxiella IgG, anti-chlamydia IgG/M, anti-tetanus IgG, anti-adevirus, anti-b. pertussis IgG/M/A, anti-brucella IgG/M, anti-influenza A & B (IgG/M), others (contact company for full menu) ne in U.S. ttg IgA, CCP, C. difficile A & B, measles IgM, mumps IgM varies, can be programmed by user <8 wells (breakapart)/96 wells DiaSorin Inc. Dawn Franzmeier dawn.franzmeier@diasorin.com 1951 Northwestern Ave., Stillwater, MN / ETI-Max 3/22/Germany Germany/U.S., Italy >125/>6 batch, random access/benchtop/rack 4 x 45 x 3 in/1 sq ft HBsAg, HBsAg confirm, anti-hbs, anti-hbc IgM, anti-hbc, HBeAg, anti-hbe, HCV, anti-hav IgM, anti-hav, HIV, EA(D) IgG, EBNA-IgG, VCA-IgG, VCA-IgM reverse capture, measles IgG, varicella zoster IgG, mumps IgG, H. pylori IgG, Lyme IgG & IgM combo, HSV I/II IgG, HTLV I/II, Trep-Chek syphilis IgG, CMV IgG & IgM capture, rubella IgG, toxoplasma IgG & IgM capture, ANA screen, ENA 6 screen, antidsdna, anti-sm, anti-sm/rnp, anti-ss-a, anti-ss-b, anti-jo-1, anti-scl-7, antimitochrondrial, anti-cardiolipin IgA, IgM, IgG & total, anti-β-2 glycoprotein 1, anti-thyroglobulin, anti-thyroid perixidase, anti-ccp, anti-centromere ne ne ne ne ne min. strip: 1, 8 wells; max. full plate: 96 wells, can accommodate up to 7 plates at a time enzyme immuassay/coated microwell, continuous loading/unloading 16/9 >16 hr/6 days/ /lot No., component, exp. date, test /ne, when using disposable tips 21/9/1 /liquid / 2 ul/ / / insignificant / /up to 16 x 95/ (2 of 5 interl., codabar, codes 39 & 128, plus others)/ / / / / / 2 (single point); up to 6 (for 6-point); 3 (cut/off) /once per run / each run / //2 min EIA/coated microplate open open volume dependent // / / /18/variable /liquid 1 µl 1 µl/2 µl / / /multiple/ / / / / / / varies per kit /each run / per run / //5 min Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists // / onboard/ Sunquest, Misys, Cerner, others (addt l cost) (broadcast download & host query) // daily: ne; weekly: 2 min; monthly: ne / $11, basic (3 modules)/all bed sizes/test volumes service during rmal business hours included in reagent rental 2 days on site; 2 days at vendor offices/ scalabilitymodules can be added to increase capacity; flexibilitycan perform multiple techlogies simultaneously; continuous loading and results reporting; Internet data enabled; remotely monitors session run status; remote service diagstics capable / / // / daily: 5 min; weekly: 3 min / $75,/medium- and large-sized hospitals 3 days/ selectively open system; multiple assays on a plate; Windows 2 software; continuous loading of samples, reagents, and microplates; primary tube sampling; bidirectional interface CMYK Page 4

14 June 25 C A P TODAY / 4 1 Automated immuassay analyzers Part 13 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers DiaSorin Inc. Brian Lauber brian.lauber@diasorin.com 1951 Northwestern Ave. Stillwater, MN / Liaison/1997/Germany Germany/U.S., Italy 25/1,25 batch, continuous random access/benchtop/rack 63 x 136 x 66 cm/9.9 sq ft 25 hydroxyvitamin D, intact PTH, EBV IgM, EBNA IgG, VCA IgG toxo IgG, toxo IgM, rubella IgG, dsdna, CMV IgG & I g M CEA, PSA, fpsa, CA 15-3, CA-125, CA 19-9, TPA-M, EA IgG, CMV IgG, CMV IgG avidity, toxo IgG avidity, HSV 2 IgG, HSV I/II IgM, HSV I/II IgG, HCG, β- 2 - m i c r o g l o b u l i n, HAV, HAV IgM, prolactin, LH, FSH, Sangtec 1, AFP, HCG, ferritin, TSH, FT3, FT4, T3, T4, anti-tg, TG, anti-tpo, rubella IgG, rubella IgM, HBsAg, HBsAg confirmatory, anti-hbs, anti HBc, HBc IgM, HBeAg, anti-hbe, anti-hav total, anti-hav IgM, troponin I, CK-MB, myoglobin, cortisol, C-peptide, Brahms procalcitonin, borrelia IgG & IgM, total treponema, ttg IgA, testosterone, NSE, progesterone ANA screen, cyclosporine, everolimus, HSV-I IgG autoimmune, S-1, avidity tests / Grifols USA Inc. John Medders john.medders@grifols.com 888 NW 18th Terrace Miami, FL Triturus/1999/Spain Spain/U.S., Germany 1/1, batch, random access & cont. random access/benchtop/universal carousel 28.3 x 41.3 x 34.3 in/1 sq ft system is completely open, any EIA procedure can be programmed. Infectious diseases, autoimmune diseases, endocrilogy, oncology markers, hepatitis and HIV profiles 8 min. strip: 1, 8 wells; max. full plate: 96 wells, can accommodate 4 plates at a time chemiluminescence/magnetic particle /1 7/28 days/ (12 C) /all lot information / 75/144/1,5 /liquid /72 5 µl/2 µl / /75 µl // (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 2 min 2 /28 days / / //2 min EIA/coated microwell, onboard shaker, 4 individually temperature-controlled incubators 1 8 tests on 1 4 plates 8 assays 8/96 // requires operator prehandling/preparation /<5 ppm 18/92/8 /liquid 2 µl 2 µl/3 µl / but has external waste port to drain into sink or floor drain / /5 µl /12, 13, 14, 16 mm/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 1 14 /check every month / each run / //1 2 min Modem servicing/can diagse own malfunctions/determine 2 min / / (additional) (host query) // / daily: 1 min; weekly: 2 min; monthly: 3 min / $125,/ inquire 3 days on site/ benchtop analyzer with high throughput; unique menu offering system is open, depends on reagent methodology depends on reagent methodology / onboard/ (additional) all major LISs LISunidirectional or bidirectional (host query & broadcast download) // hr /24 48 hr daily: 5 2 min; weekly: ; monthly: (includes audit trail of who replaced parts)/ $69,/3+ or higher $12, 4 days on site/ multibatch or continuous throughput EIA analyzer; user-defined menu, completely open system; easy color-coded worksheet and set up for operator; 2 probes for high-speed processing; unique cross-well washing; able to use fixed probes or disposable tips Tabulation does t represent an endorsement by the College of American Pathologists CMYK Page 4 1

15 4 2 / CAP T O D A Y June 25 Automated immuassay analyzers Part 14 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Hycor Biomedical Inc. cs@hycorbiomedical.com 7272 Chapman Ave. Garden Grove, CA Hy Tec 288/outside U.S. 1998, U.S. 1999/Netherlands Netherlands/U.S., Scotland 5/12 random batches/benchtop/rack-robotics 29.5 x 42.5 x 27.5 in/8 sq ft specific IgE, total IgE, >1, allergens; ANA scr., TG, TPO, dsdna, RF IgG, RF IgM, PR-3 c-anca, MPO p-anca & anti-mitochondrial, ENA-6 scr., SS-A, SS-B, gliadin IgG & IgA, Sm, Sm/RNP, Scl-7, Jo-1, GPC, GBM, cardiolipin IgG & IgM, cardiolipin scr.; anti-β-2 GPI; user-definable software anti-tissue transglutaminase IgA and IgG ne specific IgG, cardiolipin IgA, ssdna, total rheumatoid factor, anti-phosphatidyl serine scr., anti-phosphatidyl serine IgG, IgM, anti-tissue transglutaminase IgA and IgG ne ANCA profile, centromere allergy & autoimmune testing on fully automated system 8 (1 analyte per well; multiple analytes per well/screens; up to 8 analytes per run) 96 min. strip: 1 strip/8 wells; max. full plate: 12 strips/96 wells EIA, tube-based & microplate-based assays/activated cellulose & coated well Hycor Biomedical Inc. cs@hycorbiomedical.com 7272 Chapman Ave. Garden Grove, CA Hy Tec 48/1994/Switzerland Switzerland/U.S., Scotland 8/57 random batches/benchtop/rack-robotics 19.7 x 55 x 28 in/1.6 sq ft specific IgE, total IgE, >1, allergens; ANA scr., TG, TPO, dsdna, RF IgG & IgM, PR-3 c-anca, ENA-6 scr., SS-A, SS-B, gliadin IgG & IgA, Sm, Sm/RNP, Scl-7, Jo-1, GPC, GBM, MPO p-anca, mitochondrial, cardiolipin IgG & IgM, cardiolipin scr.; anti-β-2 GPI, user-definable software anti-tissue transglutaminase IgA and IgG ne IgG, cardiolipin IgA, ssdna, total rheumatoid factor, anti-phosphatidyl serine scr., anti-phosphatidyl serine IgG & IgM, anti-tissue transglutaminase IgA and IgG ne ANCA profile, centromere allergy & autoimmune testing on fully automated system 8 (1 analyte per well; multiple analytes per well/screens) 96-min. strip: 8 wells/1 strip; max. full plate: 12 strips/96 wells EIA, tube-based & microplate-based assays/activated cellulose & coated well varies by assay, up to 288 allergens or 8 autoimmune multiple varies by assay, up to 288 allergens or 8 autoimmune 8 hr/12 hr/ /<1 part in 1, /1/288 /liquid 1 µl, 11 µl w/ dead vol. 1 µl 5 µl, //1 µl / / // (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 1 5 /monthly / every assay / //2 3 min varies by assay, up to 48 multiple multiple 1/2-allergy, 96-autoimmune 8 hr/12 hr/ /<1 part in 1, /1/48 /liquid 1 µl, 31 µl w/ dead vol. 1 µl 5 µl, //3 µl / / // (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 1 5 /monthly / every assay / //5 min Modem servicing/can diagse own malfunctions/determine / onboard/optional 25 optional // 48 hr 7 months/4 hr daily: 1 15 min; weekly: 2 25 min; monthly: 2 25 min (includes audit trail of who replaced parts)/ $55,/all sites, variable test vols. $5,5 3 days on site/ fully automated allergy and autoimmune testing; >1, allergens; user-definable software / onboard/ 3 // 48 hr 1 months/4 hr daily: 1 15 min; weekly: 2 25 min; monthly: 2 25 min / $75,/all sites, variable test vols. $7,5 3 days on site/ fully automated allergy and autoimmune testing; >1, allergens; user-definable software Tabulation does t represent an endorsement by the College of American Pathologists CMYK Page 4 2

16 4 4 / CAP T O D A Y June 25 Automated immuassay analyzers Part 15 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Nichols Institute Diagstics Bill Wilson wilsonb@nicholsdiag.com 1311 Calle Batido, San Clemente, CA NID (4643) nicholsdiag.com Nichols Advantage Specialty System/1997/Germany U.S./U.S. >25/>35 batch, cont. random access/benchtop/rack 44 x 45 x 26 in/8 sq ft ACTH, cortisol, urinary cortisol, EPO, ferritin, stfr, CT, intact PTH, hgh, IGF-1, FT3, FT4, 3rd-gen. TSH, TG, anti-tg, anti-tpo, DHEAS, Bio-Intact PTH (I-84), 25 hydroxyvit D, direct renin, IGF BP-3, aldosterone, H. pylori IgG, Quick- IntraOperative Bio-Intact PTH (1 84), H-hCG ne ITA, TG with recovery osteocalcin 1,25 dihydroxyvit D, H. pylori IgA, total hcg, AFP, UE3, C-peptide, insulin ne IGF-I, calcitonin, Bio-Intact PTH (I-84), 25 hydroxyvit D, direct renin, aldosterone stfr, Quick-IntraOperative Bio-Intact PTH (1 84), H-hCG Olympus America Inc. Susan Watanabe susan.watanabe@olympus.com Two Corporate Center Dr., Melville, NY AU4e/22; AU4/1999/Japan Japan/U.S., Ireland >5/>1,5 cont. random access/floor-standing/rack & turntable 47.6 x 57.1 x 29.9 in/7 x 129 in α1-acid glycoprotein, α1-antitrypsin, anti-streptolysin O, apolipo. A1 & B, β- 2 - microglobulin, CRP, high-sensitivity CRP, CRP for pediatrics, C3 & C4 complement, ferr., haptoglobin, immugl. A, G, M, microalbumin, prealb., rheum. factor, transferrin, acetamin., amikacin, caffeine, carbamaz., digoxin, disopyramide, ethosux., gentamicin, lidocaine, methotrexate, N-acetylprocain., phebarb., phenytoin, primidone, procain., quinidine, salicylate, theoph., tobramycin, valp. acid, vancomycin, amphet., barb., benzodiazep., cannab., cocaine metab., ethal, LSD, methadone, methaq., opiate, PCP, propoxyphene, tox barb., tox benzo., tox tricyc., T-uptake, T4 thyrox. Also, general chemistries, enzymes, direct HDL & direct LDL ceruloplasmin, HbA1c, lithium, cholinesterase, urinary protein ne cotinine ne ne fructosamine ne chemiluminescence/magnetic particle /varies, typically 1 8 h// (17 C), requires operator prehandling, preparation /assay ID, lot No., serial No., expir. / 5x1-5 up to 48/12/15 x 1=1,5 /liquid /12 1 µl/2 µl / / 67 decibels /1 µl /1 x 75, 16 x 1 mm/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 37 min 2 /7 days / shortest interval: 4 hr, longest: 8 hr / //1 min EIA, photometric, potentiometric, calc. results/ne (all homogeneous) > /1 6, h/6 days/ (4 12 C) /reag. ID, lot No., bottle No., expir. / variable/up to 12/8,58 /liquid /permanent 2 µl per test 2 µl/25 µl optional/ /2 L per peak consump. <65 decibels /pediatric, 5 ml, 7 ml, 1 ml/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / varies by run size 1 6 /14 days / lab-defined / //24 h availability Modem servicing/can diagse own malfunctions/determine up to 55/up to 165 () / onboard/ (included in price) all commercially available LISs (broadcast download & host query) // 9 days/ daily: 1 min; weekly: 3 45 min; monthly: 5 min / $147,/3+ beds inquire 4 days at vendor offices/ the fully automated continuous random access chemiluminescence system can run specialty assays as if they are routine; bar coding of primary sample tubes, reagents, stored master curve and two-point calib.; assures ease of use and minimizes hands-on time; onboard refrigeration <1 min 133.3/4 (9 sec) / onboard/ (addt l cost) Cerner, Antrim, CCA, Chemware, Dawning, ADAC, Dynamic Healthcare, Antek, Siemens, McKesson (Data Inv.), CPSI, Meditech, Misys, Orchard, Citation (broadcast download & host query) // < >3 weeks/< daily: 3 min; weekly: 7 min; monthly: 45 min (incl. audit trail of who replaced parts)/ $13,/2 2, tests per day (depending on menu) inquire 5 days on site, 5 days at vendor offices/ open reagent system; 122-test menu includes general chemistry and homogeneous immuassay; onboard automation to repeat, reflex, or predilute samples; true random access and fast throughput; family of standardized analyzers including AU64, AU64e, AU27, and AU54 Tabulation does t represent an endorsement by the College of American Pathologists CMYK Page 4 4

17 4 6 / CAP T O D A Y June 25 Automated immuassay analyzers Part 16 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Ortho-Clinical Diagstics, a Johnson & Johnson Company Russ Potter rpotter3@ocdus.jnj.com 11 U.S. Highway 22, Raritan, NJ or Vitros ECi Immudiagstic System/1997/U.S. U.S./U.K. >2, worldwide cont. random access/floor standing/universal sample racks (circular) accommodate primary & secondary containers without need for adapters 51 x 44 x 29 in/8.9 sq ft 3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total ß-hCG, estradiol, progesterone, LH, FSH, prolactin, N-telopeptide, CEA, AFP, CA 125 II, CA 15-3, ferritin, cortisol (serum and urine), CK-MB, troponin I, ahbs, B12, folate, RBC folate, equimolar PSA, HBsAg, ahcv, HBsAg (conf.), myoglobin, ahbc, ahbc IgM, ahbs, testosterone ne ne CA 19-9, fβ hcg, a-hav IgM, a-hbe, HBeAg, a-hiv I&II, ahav total, toxo IgG, rubella IgG ne NT-proBNP, rubella IgM, toxo. IgM, CMV IgG, CMV IgM ne NTx Ortho-Clinical Diagstics, a Johnson & Johnson Company Russ Potter rpotter3@ocdus.jnj.com 11 U.S. Highway 22, Raritan, NJ or Vitros ECiQ Immudiagstic System/24/U.S. U.S./U.K. / cont. random access/floor standing/circular universal sample trays accommodate primary & secondary containers without need for adapters 51 x 44 x 29 in/8.9 sq ft 3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total ß-hCG, estradiol, progesterone, LH, FSH, prolactin, N-telopeptide, CEA, AFP, CA 125 II, CA 15-3, equimolar PSA, ferritin, B12, folate, RBC folate, cortisol (serum and urine), CK-MB, troponin I, myoglobin, HBsAg, ahbs, ahcv, HBsAg (conf.), ahbc, ahbc IgM, testosterone ne ne a-hav IgM, a-hbe, HBeAg, a-hiv I&II, CA 19-9, free β hcg, ahav total, toxo IgG, rubella IgG ne rubella IgM, toxo. IgM, CMV IgG, CMV IgM, NT-proBNP ne N-telopeptide chemiluminescence (enhanced)/individual coated microwell 2 2 programmed & calibrated at once; up to 25 lots calibrated per assay 2/1 56 days/56 days/ (2 8 C) /test ID, expir., lot No., pack ID /zero carryover 36/6/4 /liquid 1 µl 1 µl/6 µl but it is available/ / 6 decibels /mult. ped., microtainers & cups, 5mL, 7mL, 1mL on same univ. sample tray/ (2 of 5 interl., codabar, codes 39 & 128, & ISBT 128)/ / / / / / 1 3 /28 days / once per day / //immediate upon completion of last sample metering chemiluminescence (enhanced)/individual coated microwell 2 2; up to 25 lots calibrated per assay 2/1 56 days/56 days/ (2 8 C) /test ID, expir., lot No., pack ID /zero carryover 36/6/4 /liquid 1 µl 1 µl/6 µl, but it is available/ / 6 decibels /mult. ped., microtainers & cups, 5mL, 7mL, 1mL on same univ. sample tray/ (2 of 5 interl., codabar, codes 39 & 128, & ISBT 128)/ / / / / / 1 3 /28 days / once per day / //immediate upon completion of last sample metering Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists 24 min immediate upon completion of last sample metering 3/9 (4 sec) / onboard/ Cerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA, Citation, DHCP, Unisys, McKesson, PathLab 3, Soft, LabForce, DynaMedix, Dynacore, Psyche, Ascent, PHCP, INS, Siemens, Dawning (broadcast download) (all systems) // <4 hr (contract dependent) /dependent on corrective action daily: <5 min; weekly: <3 min; monthly: <1 min / $14,/flexible for majority of customer demand varies w/ service level choices 3.5 days at vendor offices/, as needed on site uses proprietary Intellicheck Techlogy to perform, monitor, document, and verify diagstic checks throughout sample and assay processing to significantly reduce the potential of misreported results; exclusive IntelliReport providing real-time status and traceability on the quality of reported results; uses patented Enhanced Chemiluminescence, MicroWell techlogy; provides simple to use, fully automated, true random access, stat testing for routine and specialty immudiagstic testing 24 min immediate upon completion of last sample metering 3/9 (4 sec) / onboard/ Cerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA, Citation, DHCP, Unisys, McKesson, PathLab 3, Soft, LabForce, DynaMedix, Dynacore, Psyche, Ascent, PHCP, INS, Siemens, Dawning, others (broadcast download) (all systems) // <4 hr (contract dependent) dependent on corrective action/dependent on corrective action daily: <5 min; weekly: <3 min; monthly: <1 min / $15,/flexible for majority of customer demand varies w/ service level choices as needed on site, 3.5 days at vendor offices/ uses proprietary Intellicheck Techlogy to perform, monitor, document, and verify diagstic checks throughout sample and assay processing to reduce the potential of misreported results; exclusive IntelliReport providing real-time status and traceability on the quality of reported results; uses patented Enhanced Chemiluminescence, MicroWell techlogy; provides simple to use, fully automated, true random access, stat testing for routine and specialty immudiagstic testing; features enhanced ergomics with adjustable flat, low-glare touchscreen monitor and keyboard platform with a multi-purpose support arm CMYK Page 4 6

18 4 8 / CAP T O D A Y June 25 Automated immuassay analyzers Part 17 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Pharmacia Diagstics AB Lorraine Damico lorraine.damico@diagstics.com 4169 Commercial Ave. Portage, MI ImmuCAP 25 system/24/japan, Sweden Japan, Sweden/Sweden 24/28 continuous random access/floor standing/racks 73 x 5 x 3 in + 26 in wide computer stand/ greater than 55 ImmuCAP specific IgE tests, ImmuCAP total IgE, and ImmuCAP specific IgG* tests *specific IgG is for investigational use only Pharmacia Diagstics AB ImmuCAP assays Pharmacia Diagstics AB Lorraine Damico lorraine.damico@diagstics.com 4169 Commercial Ave. Portage, MI ImmuCAP 1 system/23/japan, Sweden Japan, Sweden/Sweden 27/~2 continuous random access/floor standing/racks 83 x 71 x 4 in + 26 in wide computer stand/ greater than 55 ImmuCAP specific IgE tests, ImmuCAP total IgE, and ImmuCAP specific IgG* tests *specific IgG is for investigational use only Pharmacia Diagstics AB ImmuCAP assays fluoroenzyme immuassay (FEIA)/ImmuCAP cellulose polymer matrix reaction wells 3 methods t limited, though inventory manager software will instruct operator of reagent insufficiencies in the onboard inventory, closed system 3/4 or 1 depending on the conjugate type 5 days/1 yr/ (2 8 C) (wash solution requires preparation) /product name, lot No., expiration date / 47/5 simultaneously/37 tests /liquid 4 µl 4 µl/4 2 µl (varies with tube type) / /1 L 65 dba /1 17 mm x 5 15 mm/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 1 min 6 per analyte for calibration run, and 2 per analyte when using stored curve /28 days or sooner if conjugate lots change / once per work shift (user defined) / //3 minutes unattended fluoroenzyme immuassay (FEIA)/ImmuCAP cellulose polymer matrix reaction wells 3 methods t limited, though inventory manager software will instruct operator of reagent insufficiencies in the onboard inventory, closed system 3/4 or 1 depending on the conjugate type 5 days/1 yr/ (2 8 C) (wash solution requires preparation) /product name, lot No., expiration date /zero carryover (disposable sample tips) 46/2 simultaneously/2,4 tests /liquid 4 µl per test 4 µl/4 2 µl (varies with tube type) / /1 L 68 dba /1 17 mm x 5 15 mm/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 1 min 6 per analyte for calibration run, and 2 per analyte when using stored curve /28 days or sooner if conjugate lots change / once per work shift (user defined) / //3 minutes unattended Modem servicing/can diagse own malfunctions/determine 6 min 2 specimens/6 (1 minutes to first result, then 1 result per 6 seconds) / onboard/ (instrument side only) Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim,others (broadcast download & host query) // < / daily: 1 min; weekly: 1 min; monthly: 15 min / $75,/>2, 95, tests per year $5,4 (business hours only) 3.5 days at vendor offices/ allergy diagstics is our core business; these are t add-on tests; this system and reagents are designed to provide the most accurate specific allergy diagstic results and use well documented ImmuCAP techlogy; supported by a dedicated sales force to drive business development programs that help labs increase the services they offer physicians and outreach revenue for lab 6 min 8 specimens/24 (1 minutes to first result, then 1 result per 15 seconds) / onboard/ (instrument side only) Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, others (broadcast download & host query) // < / daily: 1 min; weekly: 1 min; monthly: 15 min / $235,/>95, tests per year $18, 4.5 days at vendor offices/ allergy diagstics is our core business; these are t add-on tests; this system and reagents are designed to provide the most accurate specific allergy diagstic results and use well documented ImmuCAP techlogy; supported by a dedicated sales force to drive business development programs that help labs increase the services they offer physicians and outreach revenue for lab Tabulation does t represent an endorsement by the College of American Pathologists CMYK Page 4 8

19 5 / CAP T O D A Y June 25 Automated immuassay analyzers Part 18 of 22 Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers Pharmacia Diagstics AB Lorraine Damico lorraine.damico@diagstics.com 4169 Commercial Ave. Portage, MI ImmuCAP 1 E system/1995/sweden Sweden/Sweden ~3/4, batch/benchtop/carousel 18 x 28 x 24 in + computer/ greater than 55 ImmuCAP specific IgE tests, ImmuCAP total IgE, gliadin IgA, gliadin IgG are FDA-cleared; and ImmuCAP specific IgG tests*, ECP*, trytase* are IUO ELIA, autoimmune products (available in U.S. through Scimedx); Celikey ttg (tissue transglutinase) IgA, IgG *ImmuCAP specific IgG tests, ECP, trytase are investigational use only (IUO) Pharmacia Diagstics AB ImmuCAP assays Randox Laboratories Ltd. Julie Thomson evidence.support@randox.com Diamond Rd. Crumlin, County Antrim, BT29 4QY 44 () Evidence/24/United Kingdom United Kingdom/United Kingdom / batch/floor standing/carousel 66 x 78 x 39 in/35.75 sq ft cocaine, amphetamines, methadone, PCP, opiates, cannabiids, barbiturates, progesterone, prolactin, LH, FSH benzodiazepines TT4, TT3, TSH, FT3, FT4, AFP, CA 125, CA 19-9, CA 15-3, fpsa, tpsa, hcg, CK-MB, CA III FABP, GPBB, myoglobin, troponin I, testosterone EGF, IFNγ, IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-1, MCP-1, TNF-α, VEGF allergen array, cell adhesion molecule array, anemia array, cerebral array, further cytokines and growth factors array, maternal screen array, platelet activation and vasoactive agents, additional tumor markers, breast cancer diagsis and classification, bone markers, drugs of abuse array II IL-1β, IL-4, VEGF, EGF, MCP-1, IFN-γ, FABP, GPBB, CAIII fluoroenzyme immuassay (FEIA)/ImmuCAP cellulose polymer matrix reaction wells 4 7, closed system depending on the conjugate type (wash solution requires preparation) /product name, lot No., expiration date / 18 min/varies with analyte/48 /liquid 4 µl per test 4 µl/4 2 µl (varies with tube type) / /1 L per run /1 16 mm x 5 15 mm/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 2.5 hr batch run 6 per analyte for calibration run, and 2 per analyte when using stored curve /28 days or sooner if conjugate lots change / once per work shift (user defined) / //2 min including request entry or downloading chemiluminescence/biochip techlogy / 3 days/3 days/ (4ºC) / / /18/ /liquid 7 ul 7 ul/5 ul / 6 decibels /12 mm, 16 mm others on request/ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 9 /weekly / user defined / //12 min Modem servicing/can diagse own malfunctions/determine Tabulation does t represent an endorsement by the College of American Pathologists batch analyzer/48/18 min processing time for batch to finish / onboard/, instrument side only (included) Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, others (broadcast download & host query) //, swap / daily: 5 minr; weekly: 1 minr; monthly: 15 min / $22,/>7, 2, tests per year $2,5 (swap contract only) 3.5 days at vendor offices/ allergy diagstics is our core business; these are t add-on tests; this system and reagents are designed to provide the most accurate specific allergy diagstic results and use well documented ImmuCAP techlogy; supported by a dedicated sales force to drive business development programs that help labs increase the services they offer physicians and outreach revenue for the lab 135/45/45 min / onboard/ (included) Torex LIMS/Clinisys LIMS (host query) // /1 day daily: <5 min; weekly: 1 min; monthly: 3 min / $275,/5+ beds, 4 tests per day 5 days on site/ biochip enables simultaneous detection of multiple parameters in a single patient sample; arrays contain multiple test panels applicable to clinical research applications and specific disease groups; tests t reported may be retrieved and reported retrospectively; cost is based soley on number of tests reported; max throughput of 1,35 test results per hour; common reagents for all tests; new panels available for research markers, such as cytokines and growth factors, drugs of abuse CMYK Page 5

20 5 2 / CAP T O D A Y June 25 Automated immuassay analyzers Part 19 of 22 Roche Diagstics Adam Sterle a d a m. s t e r l r o c h e. c o m 9115 Hague Rd. Indianapolis, IN Elecsys 21/1996/ Japan/Germany >6/>4, cont. random access/benchtop/rack or disk 22.1 x 47.2 x 28.7 in/9.4 sq ft TSH, FT4, T4, T3, FT3, T-uptake, LH, FSH, progest., estradiol, prolac., testost., CK-MB, TNT, myglobin, digoxin, PSA (screen), CEA, CA 125, AFP, ferr., B12, fol., RBC folate, IgE, intact PTH, hcg, cortisol, insulin, fpsa, DHEAS, β hcg, CA 15-3, anti-tpo, serum β crosslaps, pro BNP, cortisol urine, anti-hbs, SHBG, C-peptide Roche Diagstics Adam Sterle a d a m. s t e r l r o c h e. c o m 9115 Hague Rd. Indianapolis, IN Elecsys 11/1997/ Switzerland/Germany >2/>2, random access/benchtop/sample disk 25.6 x 37 x 25.2 in/6.5 sq ft TSH, T3, T4, T-uptake, FT3, FT4, FSH, LH, prolac., progest., estradiol, testost., CK- MB, TNT, myogl., digoxin, CEA, AFP, PSA (screen), CA 125, ferr., IgE, intact PTH, hcg, cortisol, insulin, fpsa, DHEAS, β-hcg, CA 15-3, anti-tpo, serum β crosslaps, pro BNP, cortisol urine, SHBG, 9-minute PTH, C-peptide Tests cleared but t clinically released Tests t available in U.S. but submitted for clearance Tests t available in U.S. but available in other countries Tests t available on other manufacturers analyzers TG CA 19-9, anti-hbs, HBsAg, HBsAg confirm osteocalcin, anti-hbc, cyfra 21-1, anti HBc IgM, anti-hbe, HBeAg, CA 72-4, NSE, anti-tg, PINP, anti-hcv, digitoxin ne ne TNT TG CA 19-9 osteocalcin, cyfra 21-1, CA 72.4, NSE, anti-tg, PINP ne ne TNT electrochemiluminescence/magnetic particle / days/56 days/ (2 C) /calib. curve, application params., lot No., expir., reag. name /zero carryover (disposable sample tips) 12/disk: 3, rack: 1/18 /liquid / 1 µl 1 µl/1 µl / / /13 16 mm diam./ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 2 /monthly / once per / //4 min electrochemiluminescence IA/ magnetic particle 6 6/ days/28 days/ /calib. curve, application params., lot No., expir., reag. name /<8 ppm 15/42 1 tube + 24 sample cups/128 /liquid /128 1 µl 1 µl/1 µl / / / /13 16 mm diam./ (2 of 5 interl., codabar, codes 39 & 128)/ / / / / / 2 /7 days / once per / //5 min Modem servicing/can diagse own malfunctions/determine 9 min (hcg intact) 42 sec 3/88 (42 sec) / onboard/ (addt l cost) all major LISs (broadcast download & host query) (CLAS & Roche task targeted automation) // < / daily: 1 min; weekly: 5 min; biweekly: 25 min; monthly: ne / (training CD-ROM) varies, based on contract included w/ reagent rental 3 days at Indianapolis offices/ connectable to Clinical Lab Automation System; liquid ready-to-use reagents; autocalib., autodil.; ECL techlogy for broad dynamic ranges, and fast turnaround time, stat interrupt; onboard reag. storage; minimal maintenance 9 min (hcg intact) 65 sec 2/55 (65 sec) / onboard/ (addt l cost) all major LISs (broadcast download & host query) // < / daily: 1 min; biweekly: 5 min; monthly: 5 min / varies, based on contract included w/ reagent rental 3 days at Indianapolis offices/ liquid ready-to-use reagents; autocalib., autodil.; ECL detection system provides broad measuring range and short TAT; stat interrupt; onboard reagent storage; minimal maintenance; small footprint Tabulation does t represent an endorsement by the College of American Pathologists CMYK Page 5 2